FDA Warns Chinese API Manufacturer for Serious Data Manipulation

Regulatory NewsRegulatory News | 12 January 2016 |  By 

The US Food and Drug Administration (FDA) has warned China-based Zhejiang Hisun Pharmaceutical, which established a joint venture with Pfizer in 2012, for data integrity violations more than three months after banning the company’s products from entering the US.

Specifically, the warning letter released Tuesday for the Chinese active pharmaceutical ingredient (API) manufacturer was for failing to stop unauthorized access or changes to company data, and failing to provide adequate controls to prevent the manipulation and omission of data.

During the inspection last March, FDA investigators discovered a lack of basic laboratory controls to prevent changes to the company’s electronically stored data and paper records.

The agency said the company also routinely re-tested samples without justification and deleted analytical data. 

“We observed systemic data manipulation across your facility, including actions taken by multiple analysts, on multiple pieces of testing equipment, and for multiple drugs,” FDA said. “You are responsible for determining the causes of these deviations, for preventing recurrence, and for preventing other deviations from CGMP.”

In addition, one of Hisun’s analysts who generated the data submitted to FDA said another employee, who was no longer with the company, had disabled the company’s audit trails, failing to track the company’s original data. 

“Your firm could not explain why the audit trail was disabled or why the original data was deleted, nor could you demonstrate whether the original results were within specification,” the agency said.

Raw data for a sample of 17 of 61 high performance liquid chromatography injections were deleted from a reported sequence as if the injections had never been performed, FDA found, and the investigator later discovered the missing data in a backup folder.

Meanwhile, from 2012 to 2014, several of Hisun’s customers complained that microbial results were out of specification (OOS) when they tested APIs upon receipt, though Hisun “concluded that the percentage of customer complaints reporting OOS microbial test results was insignificant. You attributed the customers’ OOS microbial results to test methods that differ from your own.”

A list of the company’s partners on its website include Pfizer, Sanofi, Merck and Eli Lilly.

FDA has in recent years been really cracking down on foreign manufacturers’ data integrity, with many of the warning letters similarly detailing firms’ inability to ensure their data is credible.   

Warning Letter

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